spinal cord outcomes partnership endeavor...
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Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
1
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
University of Ioannina NCT02031835
Body Weight Supported Treadmill Training (BWSTT) as Physical Therapy Treatment to Spinal Cord Injury Patients
8-88yr age SCI level NS AIS B, C, D
Time post SCI NS F/U 6wks
Began 3/2012 Greece 50 Subjects
Phase N/A Single Group Open Label
WISCI ISNCSCI Ashworth
Quality of Life DXA
Effect of BWSTT on quality of life, walking capability, spasticity, functional abilities, and bone health
University of Zurich Wings for Life NCT03534518
Body Weight Supported (BWS) overground training v. BWS treadmill training. 4 weeks of training
Age 18-70yr SCI above T12 AIS C, D Can walk 10m Speed≤1.1m/s 6MWT≤500m
Chronic SCI SCI>6m F/U 2m
Not yet begun Zurich 30 Subjects
Phase N/A RCT
Parallel Group Open Label
6MWT A study comparing overground vs treadmill for BWS training
Instituto Nacional de Rehabilitacion NCT02749357
Robotic (Lokomat) Locomotor Training 5 sessions/wk for 6 weeks, comparing training session duration of 60 minutes vs. 30 minutes
≥16yr Age SCI level NS AIS C, D
Chronic SCI SCI≥6m F/U 1yr
Began 8/2017 Mexico City 10 subjects
Phase N/A RCT
Single Blind
Gait Rite System Measures Lokomat Measures
SCIM III
Study comparing effectiveness of two Lokomat training session durations
Brooks Rehabilitation University of Florida NCT03504826
Locomotor training with Cyberdyne Hybrid Assistive Limb (HAL) and locomotor training overground with or without the HAL device. 60 sessions (5 days/week for 12 weeks).
Age 18-80yrs Level NS AIS B, C, D Can walk 10ft
Chronic SCI SCI>1yr F/U 20wks
Not yet begun Jacksonville, FL 24 subjects
Phase N/A Single Group Open Label
10MWT, 6MWT AIS
3-Meter Backward Walk Test NRS
SCI-FAP
Walking Rehabilitation After SCI: Locomotor Training Using Adaptive Robotics
Hospital Nacional de Parapléjicos de Toledo Institut Guttmann NCT03477123
Walking therapy with Exo-H2 exoskeleton vs. conventional walking therapy without robotic exoskeleton
Age 16-70yrs Level NS AIS C, D walker/crutch in walking rehab Height 1.6-1.9m
Subacute SCI Time post-SCI NS In Treatment at Study Center F/U 2m
Began 1/2016 Enrolling by invitation Multicenter Spain 20 Subjects
Phase N/A RCT
Parallel Group Single Blind
LEMS Ashworth
10MWT, 6MWT, TUG WISCI II SCIM III
Evaluation of Robotic Exoskeletons Therapy for Gait Rehabilitation in Patients With Incomplete SCI
Clinique Romande de Readaptation NCT02808078
Gait training on a treadmill equipped with an augmented (visual) reality system compared to standard gait training; each group receives 20 sessions of 30 minutes over the 4 week program
Age>18yr SCI level NS Able to walk 2 minutes
Acute/subacute SCI SCI<40days F/U 4mos
Began 1/2016 Sion, Valais, Switzerland 70 Subjects
Phase N/A RCT
Parallel Group Open Label
2 Minute Walk Test Berg Balance
Falls Efficacy ScaleSF-36 Treadmill Kinematics
Study of added benefit of augmented reality system in persons receiving treadmill gait training
Indiana University NCT03144388
High intensity stepping training in multiple environments, including overground, on a treadmill and on stairs vs. High intensity non-stepping training, including balance, strength, and cycling tasks. 20 sessions over a 6 week period
Age 18-75yr SCI C1-T10 AIS C, D Can walk without assistance
Chronic SCI SCI≥1yr F/U 6wks
Began 7/2017 Indiana 20 Subjects
Phase N/A RCT
Parallel Group Crossover
Option Single Blind
Walking Speed Walking Distance
Study of the effects of rehab activity task-specificity on locomotor recovery in persons with chronic SCI
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
2
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Indiana University NCT03714997
Comparison of two different intensities of walking training (30 one-hour sessions on a treadmill, overground, and on stairs). High intensity training will target achievement of heart rates close to 80% of heart rate reserve; lower intensity to heart rates from 30% to 40% of heart rate reserve.
Age 18-75yr SCI C1-T10 AIS C, D Must tolerate 10m of standing without hypotension
Chronic SCI SCI≥1yr F/U 8wks
Not yet begun Indiana 80 Subjects
Phase 2 RCT
Parallel Group Single Blind
10MWT Study of the effects of walking training intensity on locomotor performance.
Ohio State University University of Notre Dame NCT02821845
Motor Control Training (3 times a week for 12 wks at slow speeds) to evaluate the effect of downhill training on hip function. Comparing uninjured controls vs. locomotor trained iSCI without and with hip joint rehabilitation
18-90yr Age C1-T10 AIS C, D Can take some steps
Chronic SCI Discharged from outpatient rehab ≥6mos F/U 16wks
Began 6/2015 Columbus, OH 32 Subjects
Phase 1/2 RCT
Parallel Group Single Blind
6 minute walk test 10 meter walk test
Frontal hip loading response Neuromuscular Recovery Scale
Berg Balance QoL Score
Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Hip Function During Walking
Khon Kaen University NCT03622710
Rehabilitation therapy training to walk overground (control) or over Different Surfaces (experimental) for 5 days/week over 4 weeks
Age≥18yrs SCI level NS AIS C, D Can walk 10m with or without assistive device
Subacute/Chronic SCI>3mos F/U 6mos
Began 7/2018 Thailand 72 Subjects
Phase N/A RCT
Parallel Group Single Blind
10 meter walk test Timed Up and Go
Sit to Stand 6 minute walk test Incidence of falls
Studying the effects of walking training using different surfaces on walking abilities and other outcomes
Khon Kaen University NCT03254797
Stepping task training with- vs. without external feedback of weight loading on the training leg for 20 minute sessions, followed by 10 minutes of overground walking (session duration 30 minutes); 5 sessions/wk X 4 weeks
Age≥18yrs SCI level NS AIS NS (iSCI) Independent Ambulation without devices
Time post-SCI NS F/U 7mos
Began 4/2017 Thailand 17 Subjects
Phase N/A RCT
Parallel Group Single Blind
10 meter walk test TUG
6 minute walk test LE Strength
(5X Sit-to-Stand)
Studying whether step training with weight loading feedback will improve ambulatory function in patient with iSCI
University of Louisville NCT03036527
Studying the effects of activity-based locomotor, activity-based standing, and activity-based upper extremity ergometry training on recovery of bladder and sexual function. One hour training sessions, 5 days/wk for 80 sessions.
Age≥18yr SCI level NS (suprasacral) AIS NS Spinal Shock resolved
Chronic SCI Inpatient rehab completed F/U 5 years
Began 9/2014 Louisville, KY 30 Subjects
Phase N/A Non-random
Parallel Group Open Label
Bladder Capacity Voiding Efficiency (% voided)
Leak Point Pressure Bladder Compliance
IIEF, FSFI
Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After SCI
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
3
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Spinal Cord Injury Centre of Western Denmark NCT03690700
Active vs. Sham low-intensity blood-flow restricted exercise (BFRE): low-intensity strength training (20-30 % of max) while using circumferential cuffs during exercise adjusted to maintain arterial inflow to the muscles while preventing venous return.
Age 18-64yr Tetraplegia Elbow flex & Wrist extend strength 3-4/5 AIS A, B, C, D Speaks Danish
Subacute/Chronic SCI>1m F/U 12wks
Not yet begun Denmark 24 subjects
Phase N/A RCT
Parallel Group Sham Control Single Blind
SCAR SF-36
GRASSP UE Strength
H-Reflex, Ashworth, Tardieu VAS Pain Level TMS response
Active group upper arm cuff pressure to 30% above resting systolic BP; sham group to 50mmHg. 45m sessions 2X/wk for 8wks.
Hospices Civils de Lyon NCT03190863
Effect of Motor Imagery (MI) with neurofeedback vs. MI alone vs. Sham MI for improving grasp function in subjects with C6-7 AIS A or B SCI; three 45min sessions/wk X5 wks.
Age 18-55yr SCI level C6-7 AIS
Chronic SCI SCI>6mos F/U 19wks
Began 10/2017 France 21 Subjects
Phase N/A RCT
Parallel Group Single Blind
3D Motion analysis of grasp activities
ROM Muscle strength testing Box & Block, 9 hole peg
QIF
effect of motor imagery with or without visual neurofeedback on grasping capabilities after C6-C7 SCI
University of Miami NINDS NCT02451683
Study of motor task training with real or sham stimulation assessing electrophysiological parameters of time domain and location
18-65yr Age SCI C8 & above Some grasp and reach ability
Chronic SCI SCI≥6months F/U 5months
Began 4/2015 Miami, FL 300 Subjects
Phase N/A RCT
Crossover Open Label
Functional tests of arm/hand function
Cortical Neurophysiology Upper limb movements scale
Study of Corticospinal Function After Spinal Cord Injury
Instituto Nacional de Rehabilitacion NCT03531164
Kayak Ergometer training vs. neuroproprioceptive facilitation exercises focused on trunk control. 30 sessions (5 sessions per week for 6 weeks).
Age>16 SCI below C8 AIS NS
Chronic SCI 3m≤SCI≤12m F/U 6wks
Began 4/2016 Mexico City 18 subjects
Phase N/A RCT
Parallel Group Double Blind
Trunk Control SCIM III
Heart Rate, Blood Pressure Satisfaction with Life
questionnare
Effect of Kayak Ergometer Training in trunk control, independence and cardiovascular health in persons with SCI
University of British Columbia Rick Hansen Institute NCT02799966
MyndMove, a non-invasive medical device that uses short, low energy electrical pulses with surface electrodes to cause muscle contractions which result in UE movement. By assisting movement with MyndMove stimulation, patients may gain volitional ability
Age≥18yr C4-C7 AIS B, C, D SCIM Self-Care score ≤10 No existing e-stim device
Acute-Chronic SCI Early SCI 10d-6m Late SCI>6m F/U 7wks
Began 10/2017 Multicenter Canada 40 subjects
Phase N/A Non-
randomized Parallel
Assignment Open Label
SCIM GRASSP
TRI-HFT ARAT
Study of the effectiveness of MyndMove therapy in improving the ability of individuals to voluntarily move their arms and hands
MyndTec Inc. US Dept of Defense NCT03439319
MyndMove® therapy, a non-invasive FES technique using surface electrodes to stimulate 3-8 muscles to produce purposeful movement in the arms/hands, compared to conventional rehabilitation therapy
Age≥18yrs SCI C4-C7 AIS B, C, D SCIM-SC≤10
Chronic SCI 4m<SCI<12m F/U 24wks
Not yet begun Multicenter Canada/USA 60 subjects
Phase N/A RCT
Parallel Group Single Blind
SCIM-Self Care (SCIM-SC) GRASSP TR-HFT
ARAT Ashworth SCI-QOL
comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
4
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Milos Popovic Toronto Rehabilitation Institute NCT03658798
Forty 1 hour treatment sessions of UE surface FES utilizing a prototype FES-shirt garment (GarmentGrasp) with embedded electrodes and wires custom-positioned to enable stimulation of muscles around the hand, elbow, and shoulder
18-70yrs Age SCI C4-C7 AIS NS
Chronic SCI SCI>6m F/U 14wks
Began 10/2017 Toronto 24 Subjects (12 with SCI, 12 with stroke)
Phase N/A Single Group Open Label
TRI-HFT FIM
SCIM Grip Strength
Task performance with/without FES
Grasping rehabilitation with functional electrical stimulation garment (GarmentGrasp)
Northwell Health NCT03385005
Up to 4 sessions weekly for up to 8 weeks of transcutaneous electrical stimulation on the forearm using an investigational neuromuscular stimulator in order to evoke different hand and finger movements
Age 18-65yrs C5 motor level No volition C6-T1 segments AIS A
Chronic SCI SCI ≥1yr F/U 8wks
Began 9/2017 New York 15 subjects: 3-10 healthy volunteers; 2-5 subjects with SCI
Phase 1 Sequential
Assignment Open Label
Refined Hand Movement Force Measurement of Wrist &
Finger Movement
Evaluating Neuromuscular Stimulation for Restoring Hand Movements
SCI Centre of Western Denmark Aarhus University Hospital Regionshospitalet Viborg University of Southern Denmark NCT03441256
laparoscopic implantation of neuroprosthesis (LION) electrical stimulation of the lumbosacral plexus vs. conventional surface electrode neuromuscular electrical stimulation
Age 18-45yrs SCI T6-L1 AIS A, B
Chronic SCI SCI≥12m F/U 12m
Began 1/2018 Denmark Enrolling by invitation 20 Subjects
Phase N/A RCT
Parallel Group Open Label
WISCI III Electrophysiology
Lower Urinary Tract Function Bowel Function
QoL Brief Pain Inventory
Study of Motor, Sensory, and Autonomic Function After LION stimulation of the lumbosacral plexus
Louis Stokes VAMC NCT01570816
Device: IRS-8 (8 channel implanted receiver stimulator) to study the effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
18-75yr age Impaired walking due to chronic partial paralysis Walk ≥10 with min assist
Chronic iSCI SCI≥6m F/U up to 36m
Began 4/2012 Cleveland, OH 6 Subjects
Phase 1 Single Group Open Label
Analyses of speed, distance and quality of walking with and
without stimulation Feasibility of initiating a step with
a trigger from an accelerometer incorporated in the external
control unit.
Surgical implantation to stimulate paralyzed muscles of the lower extremities
Clinique Beau Soleil University Hospital, Montpellier NCT03721861
Intra-operative neural cuff stimulation. A feasibility study for placement of 2 electrodes around the radial or medial nerves intraoperatively during tendon transfer surgery to restore elbow extension
Age 18-65yr NLI≥C7 AIS A, B Undergoing surgery to restore elbow extension
Chronic SCI SCI>6m F/U 1wk
Began 2/2016 Montpellier, France 9 subjects
Phase N/A Single Group Open Label
Selectivity of cuff electrode nerve stimulation responses for activation of UE muscle
contractions
Neural Functional Electrical Stimulation for the recovery of grasping movements for patients with tetraplegia
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
5
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Case Western Reserve University NINDS FDA OOPD NCT02329652
Implantation and use of networked neuroprosthesis system (NNS) for arm, hand and trunk function.
Age≥17yr Motor level C4-8 AIS A, B, C, D Elbow flex≥2/5
Chronic SCI≥6m F/U 3m
Began 12/2014 Cleveland 10 Subjects
Phase N/A Single Group Open Label
ADL Abilities Test Grasp-Release Test
implanted device for providing hand function, reach, and trunk function to individuals with cervical SCI
Case Western Reserve Univ. MetroHealth Medical Center NINDS NCT01659541
Implantation of spinal cord expiratory muscle stimulator wire leads to restore cough
18-75yr Age SCI C8 or above AIS NS Expiratory muscles weak
Chronic SCI AIS A: SCI≥6m AIS B, C, D ≥12m F/U 2yrs
Began 4/2015 Cleveland, OH 16 Subjects
Phase N/A Single Group Open Label
Peak Expiratory Flow Maximum Airway Pressure Caregiver Burden Inventory
Secretion Management Index Incidence of Resp. Infections
SCI related Quality of Life
determine efficacy of spinal cord stim, with wire leads, to produce effective cough in patients with SCI
Case Western Reserve University NIH VA Office of Research and Development NCT00623389
Device: IST-16 (16-channel implanted stimulator-telemeter) with pre- and post-surgical training to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis
Age≥18yr C6-T12 or other paralysis AIS A, B, C Normal ROM
Chronic SCI SCI≥6m F/U 12m
Began 5/2005 Cleveland, OH 10 Subjects
Phase N/A Single Group Open Label
Standing, walking and balance performance
Standing duration, reachable workspace, and ability to perform other functional activities of daily
living
Evaluation of an Advanced Lower Extremity Neuroprostheses
Dept. of Veterans Affairs NIH NCT01923662
Device: IST-16 (16-Channel implanted stimulator-telemeter) for standing in persons with paralysis resulting from neurological disorder such as low cervical/thoracic spinal cord injuries (C6-T12)
Age≥21yrs C6-T12 AIS NS
Chronic SCI SCI≥6m F/U 12m
Began 4/2013 Cleveland, OH 10 Subjects
Phase N/A Single Group Open Label
Elapsed Standing Time for different stimulation paradigms Subject Impression of Stability
Body Weight Distribution Standing Stability Measures
multiple-contact peripheral nerve cuff electrodes to selectively activate portions of a muscle to improve fatigue characteristics
VA Office of R&D NCT01474148
Device: IRS-8 (8-Channel implanted stimulator-telemeter) to facilitate stability of the trunk and hips; Study the effect of stabilizing and stiffening the trunk with FES to change the way persons with SCI sit, breathe, reach, push a wheelchair, roll in bed
Age≥21yr C4-T12 AIS A, B, C
Chronic SCI SCI≥6m F/U up to 36m
Began 7/2011 Cleveland, OH 10 Subjects
Phase N/A Single Group Open Label
Effect of Trunk stimulation on control seated posture,
respiration, seated interface pressures, reach ability, seated stability & personal mobility
Surgical implantation of an 8 channel FES system to facilitate stability of the trunk and hips
Palo Alto Veterans Institute for Research NCT02978638
Implantation of Finetech Vocare Bladder System—a sacral nerve root stimulator. The study tests the use of the system to inhibit bladder contractions by electrically stimulating sensory nerves (as an alternative to cutting sensory nerves).
Age≥22yr SCI below C4 AIS A Dyssynergia Detrussor Hyper-reflexia
Chronic SCI SCI≥2yr F/U 12m
Began 9/2014 Palo Alto, CA 10 Subjects
Phase N/A Single Group Open Label
Bladder Capacity (Cystometry) Frequency of Incontinence
Restoration of Bladder and Bowel function using electrical stimulation and block after SCI
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
6
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Swiss Paraplegic Centre Nottwill NCT03048331
Surface Functional Electrical Stimulation (FES) in persons who have had Upper Extremity reconstructive surgery (tendon and/or nerve transfers) to determine if the additional of FES vs. standard therapy can improve motor learning and functional outcomes after these surgeries
Age≥18yr SCI C4-T1 AIS A, B, C, D Planned UE reconstructive surgery
Chronic SCI SCI>6m F/U 16wk
Began 3/2017 Switzerland 30 Subjects
Phase N/A RCT
Parallel Group Open Label
Force, Power of treated muscle COPM
Surface EMG Treatment Effectiveness
(Questionnaire) Ultrasound (Muscle Volume)
Pilot Study of FES in in persons with tetraplegia who receive UE reconstructive surgery
University of Louisville UCLA Reeve Foundation Kessler Foundation NCT02339233
Implantation and use of spinal epidural 16 electrode array for spinal cord electrical stimulation to facilitate standing and stepping in persons with SCI receiving locomotor training.
18-75yr Age SCI above T10 Unable to stand or step independently
Chronic SCI SCI ≥1yr F/U 20m
Began 1/2010 Louisville 10 Subjects
Phase N/A Single Group Open Label
Voluntary Movement Spinal Epidural Electrode Array to Facilitate Standing and Stepping After Spinal Cord Injury
University of Louisville NCT03364660
Spinal Cord Epidural Stimulation utilizing stim parameters for voluntary movement, standing, or cardiovascular responses combined with leg movement training or stand training while sitting or supine.
Age≥18yrs SCI level NS Unable to move legs/stand
Chronic SCI SCI≥2yrs F/U 20m
Began 11/2017 Louisville 36 subjects
Phase N/A RCT
Parallel Group Open Label
Cardiovascular Assessments Functional Movement
Assessments Standing Assessments
Task & Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing
U of Minnesota NCT03026816
Implanted epidural spinal cord stimulator for improving volitional motor activity autonomic function in persons with chronic motor complete SCI; comparing outcomes with stimulator on vs. off (sham stimulation).
Age≥22yr SCI C6-T10 AIS A, B
Chronic SCI SCI>1yr F/U 15m
Began 8/2017 Minneapolis 100 Subjects
Phase N/A Single Group
Single Blinded Outcome (BMCA)
Brain Motor Control Assessment Volitional Movement
Sympathetic Skin Response Blood Pressure
Cerebral Blood Flow (tilt table) Arterial Stiffness
Optimization of Epidural Stimulation parameters for Chronic Motor Complete SCI
Shirley Ryan AbilityLab NCT02991248
Three arm study comparing robotic/pelvic force-perturbation treadmill training with 1) active vs. 2) sham transcutaneous spinal direct current stimulation (tsDCS), and 3) standard treadmill training only. Three treatment sessions per week for 6 weeks.
18-65yr Age SCI C4-T10 AIS C, D Able to walk 10 meter with no more than AFO
Time after SCI NS F/U 14wk
Not yet begun Chicago 54 subjects
Phase N/A RCT
Parallel Group Single Blind Assessments
Gait Speed (overground) 6 minute walk test
Dynamic Gait Index Berg Balance Scale
whether pelvis perturbation training with tsDCS will be effective in improving dynamic balance and locomotor function
University of Zurich NCT03137108
Transcutaneous electrical spinal cord stimulation (tSCS) using RehaMove 3 stimulator applied during standing and overground walking in FLOAT body-weight support system. 2 sessions within 2 weeks.
Age≥18yr SCI above T12 AIS C, D Can walk 10 m independently
Subacute SCI 3-12m Chronic SCI≥12m F/U 2 wks
Began 10/2017 Zurich, Switzerland 15 subjects
Phase N/A Single Group Open Label
Kinematic Movement Motion Capture
Force Plate
effects of tSCS with different stimulation modalities on voluntary motor in persons with iSCI
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
7
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Hugo Moser Research Inst. Kennedy Krieger, Inc. NCT03384017
Transcutaneous Spinal Cord Stimulation (TSCS) via skin surface electrodes. Subjects will participate in 24 two hour sessions with 30 minutes of TSCS and strengthening, task practice and gait-based therapy—gait training will continue after TSCS.
Age 18-65yrs SCI above T10 AIS NS
Chronic SCI SCI>1yr F/U 8wks
Began 1/2017 Baltimore 10 Subjects
Phase N/A Single Group Single Blind
10MWT TUG
WISCI II 6MWT
Impact of TSCS & Gait Training on Walking Function in Patients With SCI
University College, London Neurokinex Inspire Foundation Royal National Orthopaedic Hospital NHS Trust NCT03536338
Electrical stimulation applied to the skin surface at the lower back with sit-to-stand training vs. sit-to-stand training alone. 3 sessions per week for 8 weeks.
Age>18yrs C5-T12 SCI AIS A, B, C, D Unable to stand from chair unaided
Chronic SCI SCI>1yr F/U 8wks
Not yet begun London, UK 10 subjects
Phase N/A Non-random
Parallel Group Open Label
LE Motor Control (EMG) Sit-to-stand Performance
QoL Urodynamics
Spinal Stimulation Sit-to-Stand Training After Spinal Cord Injury (Stim2Stand)
University of Florida NIH NICHD NCT03702842
transcutaneous direct current stimulation (tsDCS) of the spinal cord utilizing Soterix Medical tsDCS stimulator over the low back during locomotor training. Part 1: 2 sessions with different stimulation levels; Part 2: 16 sessions of locomotor training with one of the two tsDCS dosages
Age 18-65yr NLI T12 or above AIS C, D Can walk 10ft with/without aids/assist
Chronic SCI SCI>1yr F/U 4wks
Not yet begun Jacksonville, Florida 20 Subjects
Phase N/A RCT
Parallel Group Single Blind (Participant)
10MWT EMG
6MWT
Study to explore effects of tsDCS applied during walking in adults with chronic iSCI
University of Louisville NCT03452007
Epidural Spinal Cord Stimulation with 16 electrode array allowing determination of stimulation parameters and electrode configurations that result in improved bladder capacity and voiding efficiency
Age>18yrs Have implanted stimulator SCI above sacral segments AIS A, B
Chronic SCI SCI>2yrs F/U 2yrs
Not yet Begun Louisville 6 subjects
Phase N/A Single Group Open Label
Urodynamics Bladder Capacity Bladder Pressure
Voiding Efficiency Rectal pressure
Functional Mapping With Lumbosacral Epidural Stimulation for Restoration of Bladder Function After SCI
Shepherd Center NCT03240601
30 minute sessions of Active vs. Sham comparator Transcutaneous Spinal Cord Stimulation (tcSCS) for reducing spasticity and improving walking function in participants receiving locomotor training
18-65yr Age SCI T11 or above Able to take a step with or without assistive device; has spasticity in LE
Chronic SCI Enrolled in inpatient rehab or outpatient Day Program at Shepherd Center
Began 7/2017 Atlanta, GA 28 subjects
Phase N/A RCT
Parallel Group Triple Blind
Pendulum/Leg Drop Test 10 meter walk test 2 minute walk test
Ankle Clonus/foot drop test Other assessments of spasticity
Borg Perceived Exertion Tolerance of stimulation
Combined Influence of Transcutaneous Spinal Cord Stimulation and Locomotor Training on Spasticity and Walking Outcomes
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
8
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Kessler Institute Kessler Foundation NCT03096197
Transcutaneous lumbosacral stimulation (TLS) with Exoskeleton Assisted Walking (EAW) compared to EAW alone for recovery of walking. Each group receives 80 sessions of treatment (60 minutes of EAW+TLS or EAW alone, with EAW+TLS group also receiving 15 minutes of overground training without EAW.
Age 21-58yrs SCI C6-T10 AIS C, D LEMS≥16 Non-walking Wheelchair user
Chronic SCI SCI>6yrs F/U 28wks
Began 03/2017 New Jersey 24 Subjects
Phase N/A RCT
Open Label
6 minute walk test (6MW) 10 meter walk test (10MW)
Berg Balance Scale LEMS
Study of the effect of adding TLS to EAW on walking recovery in persons with chronic non-ambulatory incomplete SCI
City University of New York Bronx Veterans Medical Research Foundation, Inc NCT03669302
20 sessions of low(0.3Hz)- vs. high(30Hz)-frequency transspinal (surface electrical) stimulation in persons receiving robotic gait training to improve LE motor function after motor incomplete SCI
18-65yr Age SCI above T12 (vertebral) AIS C, D
Chronic SCI SCI≥6m F/U 3yr
Began 8/2018 New York 45 Subjects
Phase N/A RCT
Parallel Group Open Label
Neurophysiological Testing TMS responses
H-Reflex ISNCSCI
Tardieu Scale (spasticity) 2MWT, 10MWT
Activity-Dependent Transspinal Stimulation for Recovery of Walking Ability After SCI
U of Washington NCT03509558
Transcutaneous cervical and lumbosacral electrical stimulation with intensive walking and standing physical therapy vs. intensive walking and standing physical therapy alone. 2hr/day, 2-5d/week.
21-70yr Age SCI T12 or higher Incomplete SCI
Chronic SCI SC≥1yr F/U 11m
Began 2/2018 Seattle, WA 10 subjects
Phase N/A RCT
Crossover Open Label
Neuromuscular Recovery Scale ISNCSCI
SSEP, MEP Berg Balance, 6MWT, 10MWT
Kinematics SCI-QOL, SCI-FI
Transcutaneous Spinal Stimulation and Exercise for Locomotion
U of Washington NCT03184792
Upper extremity rehabilitation exercise therapy with- or without transcutaneous spinal cord stimulation
21-70yr Age SCI Level C7 or higher Impaired hand function
Chronic SCI SCI≥1yr F/U 6m
Began 12/2016 Seattle, WA 10 Subjects
Phase N/A RCT
Open Label Crossover
GRASSP, ISNCSCI SCIM
Spasm Score Grip & Pinch Strength
Pain Rating Scale SSEP, MEP
Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in SCI
Vanderbilt University Med Ctr NCT02899858
IntraSpinal Micro-Stimulation (ISMS) with up to 16 electrodes implanted during clinically indicated spinal surgery along each side of the spinal cord at levels that correlate with hip, knee, and ankle segmental innervation.
18-50yr Age T2-T8 Undergoing surgery allowing T9-12 laminectomy AIS A
Chronic SCI SCI>1yr F/U 3yr
Began 1/2015 Nashville, TN 2 Subjects
Phase N/A Single Group Open Label
Intraoperative Movement Post-Operative Kinesiology
Microstimulation of the spinal cord for restoration of standing and walking in persons with chronic complete SCI
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
9
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
C. Hospitalier Univ. Vaudois Ecole Polytechnique Federale de Lausanne NCT02936453
Implanted closed-loop Epidural Electrical Stimulation (EES) combined with over-ground robot assisted rehabilitation training (STIMO) for improving ambulation in persons with chronic incomplete SCI
18-65yr Age T10 and above AIS C, D Can stand with walker/crutches
Chronic SCI SCI≥12m F/U 8-12m
Began 7/2016 Lausanne, Switzerland 8 Subjects
Phase N/A Single Group Open Label
WISCI 10 Meter Walk, 6 Minute Walk
Weight Bearing Capacity AIS, SCIM III
Berg Balance, Pain Assessment Kinematics, EMG Electrophysiology
Single group study of the combination of closed-loop EES with robotic assisted rehabilitation in chronic iSCI
University of Miami NINDS NCT02446210
Magstim 200 stimulator for Transcranial Magnetic Stimulation and electrical Peripheral Nerve Stimulation
18-65yr Age Injury above L5 Can grip bilat Can ambulate a few steps
Sub acute/Chronic SCI≥1 month F/U 5months
Began 3/2015 Miami, FL 514 Subjects
Phase N/A RCT
Crossover Open Label
Motor Cortical Excitability EEG/EMG
Enhanced motor UE Enhanced motor LE
Neural Control of Bilateral Hand, Arm, and Leg Movements After Spinal Cord Injury
Burke Medical Research Institute NCT03592173
Spinal Associative Stimulation (SAS) with repetitive and synchronized dual peripheral nerve and brain stimulation; i.e. Paired Associative Stimulation (PAS) to enhance MEP amplitude in target muscles
18-80yr Age NLI NS AIS C, D LEMS≥3 Some spared ankle flex/extend
Chronic SCI SCI>6m F/U 3wks
Began 7/2013 White Plains, New York 30 Subjects
Phase 2 RCT
Parallel Group Crossover
Open Label
H-Reflex LEMS
WISCI II 10MWT
SCIM III Muscle force, Kinematics
Testing various stimulus pairing times. Each session of three sessions includes 90 paired stimuli over 15 min
Helsinki Central University Hospital Validia Rehabilitation Centre NCT03459885
Paired Associative Stimulation (PAS) using transcranial magnetic stim paired with Lower Extremity (LE) peripheral nerve electrical stimulation administered several times per week for 8 weeks
Age 18-70yr Cervical SCI AIS B, C, D
SCI duration NS F/U 3m
Began 2/2018 Finland Enrolling by invitation 5 Subjects
Phase N/A Single Group Open Label
Manual Muscle Testing Long-term PAS for rehabilitation of LE in Persons With Incomplete Tetraplegia
Helsinki Central University Hospital Validia Rehabilitation Centre NCT03045744
Paired Associative Stimulation (PAS) using transcranial magnetic stim paired with Lower Extremity (LE) peripheral nerve electrical stimulation administered several times per week for as long as continuous improvement is observed
Age 18-70yr SCI level NS AIS B, C, D
SCI duration NS F/U until 1m after last stimulation session
Began 2/2017 Finland Enrolling by invitation 5 Subjects
Phase N/A Single Group Open Label
Manual Muscle Testing Long-term PAS for rehabilitation of LE function; extending paticipation for as long as improvement is observed
Helsinki Central University Hospital Validia Rehabilitation Centre NCT03104803
Paired associative stimulation (PAS) using transcranial magnetic stim paired with upper extremity (UE) peripheral nerve electrical stimulation administered several times per week for 6 weeks to one hand.
Age 18-70yr SCI level NS incomplete non-traumatic SCI only
SCI duration NS F/U until 1m after last stimulation session (i.e. 10wks)
Began 3/2017 Finland Enrolling by invitation 5 Subjects
Phase N/A Single Group Open Label
Manual Muscle Testing Long-term PAS as a treatment for incomplete SCI of non-traumatic origin
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
10
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
VA Office of R&D University of Miami NCT03447509
Transcranial non-invasive Magnetic Stimulation targeting late indirect descending volleys (iTMS) (vs. sham iTMS) with acoustic startle during performance of UE movement tasks/training
Age 18-85yrs SCI above L5 AIS A, B, C, D Visible grip/UE movement ability
Chronic SCI SCI>2m F/U 60minutes
Began 8/2018 Miami 300 Subjects
Phase N/A RCT
Crossover Single Blind
(subject)
Motor Evoked Potential Amplitude
Grip Strength 9-Hole Peg Test
Testing the effects of iTMS protocol on grasping function after SCI
Spinal Cord Injury Centre of Western Denmark University of Southern Denmark NCT03690726
Active vs. sham Repetitive transcranial magnetic stimulation (rTMS) combined with strength training/standard of care rehabilitation
18-50yr Age NLI NS AIS B, C, D
Subacute/Chronic SCI<6m F/U 8wks
Not yet begun Denmark 30 Subjects
Phase N/A RCT
Parallel Group Sham Control Triple Blind
6MWT, 10MWT LEMS TUG
WISCI ISNCSCI Pain VAS
Study of rTMS effects on recovery of motor function when combined with strength training/rehab
Cleveland Clinic NCT01539109
Transcranial Direct Current Stimulation (tDCS) vs. sham tDCS in incomplete cervical SCI patients undergoing rehabilitation training
18-75yr age SCI>6m Cervical Level AIS B, C, D
Chronic SCI SCI>6m F/U 3m
Began 11/2011 Cleveland 10 Subjects
Phase N/A RCT
Parallel Group Double Blind
UEMS MRI of Brain
TMS
Study of tDCS combined with training of UE in incomplete tetraplegia
Shepherd Center NCT03237234
Upright (standing) motor skills training with- or without (sham) transcranial (via scalp electrodes) direct current stimulation (tDCS) of the motor cortex of the brain, to improve walking function. Three 25-30 minute training sessions; baseline and follow-up assessments sessions.
18-65yr Age C3-T10 level AIS C, D Stand 5min Takes 3 steps
Chronic SCI SCI≥12m F/U 5 days
Began 3/2017 Atlanta, GA 35 subjects
Phase N/A RCT
Parallel Group Sham Control Double Blind
10MWT, 2MWT Ankle Dorsiflexion Strength
Gait Kinematics Berg Balance Scale Falls Efficacy Scale 5 times sit-to-stand
SCATSR
Study of tDCS for enhancing corticospinal tract activation to improve walking function
Shepherd Center NCT02611375
Transcranial Direct Current Stimulation (tDCS); Peripheral Nerve Somatosensory Stimulation PNSS; Sham (tDCS); each combined with functional task practice (FTP) to assess improvement in upper extremity function
18-65yr Age C1-C8 AIS A, B, C, D
Acute/Subacute, Chronic SCI SCI<6m SCI>1yr F/U 4-6wks
Began 1/2017 Atlanta, GA 70 Subjects
Phase N/A RCT
Parallel Group Sham Control Double Blind
GRASSP UE Sensation (Semmes-
Weinstein) Perceived UE Performance &
Satisfaction (COPM)
Comparison of tDCS+FTP vs. PNSS+FTP vs. Sham tDCS+FTP to assess effect on UE function
Shepherd Center NCT03237091
Bi- or Unihemispheric, transcranial pulsed (tPCS) or direct (tDCS) current stimulation, vs. sham stimulation (5 different interventions). 30 minute sessions. Subjects will receive a single session of each intervention.
18-65yr Age C1-C8 Level AIS A, B, C, D Some UE impair Thumb or index volition
Time after SCI NS F/U 5 wks
Began 5/2018 Atlanta, GA 19 subjects
Phase N/A RCT
Crossover Double Blind Sham Control
Motor control and strength Corticospinal Excitability (MEP)
Stimulation Questionnaire
Various modes of transcranial stimulation to improve functional recovery
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
11
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Burke Medical Res. Institute New York State SCI Res. Board NCT03555838
6-week hand robotic training preceded by 20 min anodal 2mA transcranial electrical direct-current stimulation (tDCS) or sham procedure (3 sessions/week, 18 sessions total)
18-99yr Age Cervical SCI AIS B, C, D Hand weakness Pick up ≥1 block in Box & Block
Chronic SCI SCI>6m F/U 10wks
Began 5/2017 New York 40 Subjects
Phase 3 RCT
Parallel Group Double Blind
Box and Blocks Test UEMS, SCIM III
Ashworth 9-hole Peg Test
QIF Chronic Pain Questionnaire
Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS
Universidade Federal de Pernambuco NCT03394560
12 sessions of active or sham repetitive transcranial magnetic stimulation (rTMS) combined with Body Weight Supported Treadmill Training (BWSTT)
Age 18-55yrs SCI below T1 AIS C, D Not community walker
Chronic SCI SCI>8 months F/U 2 months
Not yet Begun Brazil 20 Subjects
Phase 2 RCT
Parallel Group Double Blind
WISCI II AIS, LEMS SCIM III Ashworth
SF-36
rTMS & BWSTT for sensory motor recovery in persons with chronic incomplete SCI
University of Zurich NCT03053791
Unilateral implantation of a Medtronic Activa SC deep brain stimulation system in the mesencephalic locomotor region
18-75yr Age SCI T10 & above AIS C, D walk 10 meters
Chronic SCI SCI≥6m F/U 6m
Began 2/2017 Zurich, Switzerland 5 Subjects
Phase 1/2 Single Group Open Label
6 Minute Walk TUG, Ashworth
SCIM III WISCI II
SF-36 Bladder, Bowel, Sexual Function
Mesencephalic locomotor region deep brain stimulation for improvement of locomotion and gait
University of Nove de Julho NCT03031223
3 sessions/wk X 4 wks of Low Level Laser Therapy (LLLT) administered transcutaneously to the injury site at a wavelength of 808 nm using a Twin Flex Evolution diode laser vs. no LLLT control
Age NS SCI C3-L5 AIS B, C, D
Acute-Chronic SCI SCI≤1yr F/U 90d
Began 8/2016 Sao Paulo, Brazil 30 Subjects
Phase N/A RCT
Parallel Group No Blind
EMG Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of SCI
Shepherd Center NIH NCT02340910
Two durations (eight 45sec @50Hz bouts vs. sixteen 45sec @ 50Hz bouts, 5 days/wk for 4 weeks) of Whole Body Vibration compared for improvement in spasticity and walking in persons with motor incomplete chronic SCI
16-72 Yr Age T12 or higher AIS C, D
Chronic SCI SCI≥6m F/U 4wks
Began 1/2015 Atlanta 57 Subjects
Phase N/A Parallel Group
Open Label
Spasticity (Pendulum Test, SCI-SET,
Electrophysiology) Walking Speed, Endurance Pinch Strength, 9-hole Peg
Strength, Pain
Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI
NIDCD VA Office of R & D NINDS NCT00912041
Implantation of the one or two BrainGate2 sensor electrode arrays into the motor cortex; training implanted subjects to control a computer cursor and other assistive devices with their thoughts
18-75yr age Cervical SCI AIS A, B, C, D Live≤3hr drive
Time post SCI NS F/U 1yr
Began 5/2009 4 Centers, USA 15 Subjects
Phase N/A Single Group Open Label
Safety Feasibility of BrainGate2 to
establish the parameters for a larger clinical study (appropriate
neural decoding algorithms, endpoints, success criteria, etc.)
4x4 mm BrainGate2 sensor is placed into the motor cortex, connected to a percutaneous pedestal.
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
12
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
VA Office of Research and Development Case Western Reserve University NCT03482310
Use of Neuroport array to record cortical activity to train the development of brain activity correlated with appropriate grasp patterns, utilizing virtual reality and FES controlled hand movement. Eligible subjects must have been successful participants in BrainGate2 trial.
Age NS SCI with UE impairment Neuroport implant BraingGate2 participant
Chronic SCI Time post SCI NS F/U 1yr
Began 6/2018 Cleveland, OH 6 Subjects
Phase N/A Single Group Open Label
Ability to form appropriate grasp patterns
Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
California Institute of Technology UCLA Casa Colina NCT01958086
Implantation of two Neuroport electrode arrays in posterior parietal cortex allowing direct brain-control of a computer interface. Ultimate objective is to allow the patient autonomous control over the Google Android tablet operating system.
Age 22-65yr high cervical SCI Lives<60 miles from study center; not on ventilator
Time post SCI NS F/U 1yr
Began 10/2013 Pomona, CA 2 subjects
Phase N/A Single Group Open Label
Subject control of tablet computer Absence of infection or irritation
Adverse Events
Feasibility Study for Use of a Brain Implant for Neural Control of a Tablet Computer
University of Pittsburgh DARPA Dept. of Defense Johns Hopkins University NCT01894802
Implantation of microelectrode Cortical Recording and Stimulating (CRS) arrays in the motor cortex and sensory cortex of the brain for neural activity recording and use in control of external devices
22-70yr age Limited or no ability to use hands due to cervical SCI or other condition
Chronic Condition SCI≥1yr F/U 12m
Began 12/2013 Pittsburgh 5 Subjects
Phase N/A Single Group Open Label
Safety: array not removed for safety during 12 month F/U
Efficacy: long-term recording of neural activity and successful
control of external devices
Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex
University of Pittsburgh Dept. of Defense Johns Hopkins University NCT01364480
Implantation of two NeuroPort electrode arrays in the motor cortex of the brain to demonstrate the safety and efficacy for long-term recording of brain activity
18-70yr age Limited or no ability to use hands due to cervical SCI or other condition
Chronic Condition SCI≥1yr F/U 12m
Began 5/2011 Pittsburgh 5 Subjects
Phase N/A Single Group Open Label
Safety: array not removed for safety during 12 month F/U
Efficacy: long-term recording of neural activity and successful
control of external devices
Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex
University of Southern California Rancho Los Amigos NCT01964261
Implantation of 3 Neuroport electrode arrays to enable learned control of an end effector (for reach and grasp tasks) by thought augmented with sensory feedback via intracortical brain stimulation
22-65yr Age High cervical SCI AIS NS
Time after SCI NS F/U 1yr
Began 11/2013 California 2 Subjects
Phase N/A Single Group Open Label
Patient control of end effector (virtual or physical)
Absence of Infection or Irritation
Providing Closed Loop Cortical Control of Extracorporeal Devices to Patients With Tetraplegia
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
13
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
University of Miami NCT02564419
Implantion of a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex of the brain processed in an implanted Medtronic Activa PC+S connected with Bioness H200 external UE stimulator to produce hand grasp. 24 training sessions over 3-6 months
22-50yr Age C5-6 level AIS A, B
Chronic SCI Time post-SCI NS F/U 24m
Began 11/2015 Miami, FL 1 subject
Phase N/A Single Group Open Label
Neurological Exams Questionnaires
Functional Hand Testing AIS, motor/sensory scores
SF-36
Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
Northwell Health NCT03680872
Bidirectional Neural Bypass System: Implantation of microelectrode arrays into the primary motor cortex to record neural activity associated with desired movements and into the primary somatosensory cortex to deliver stimulation in order to provide sensory perception. Participation in 3 study session/wk X 12mos
22-65yr Age Motor Level C5 AIS A
Chronic SCI SCI≥1yr F/U 12m
Began 9/2018 Manhasset, New York 3 Subjects
Phase N/A Single Group Open Label
GRASSP-restoration of hand movement
Restoration of tactile sensation of the hand
Feasibility trial of brain implantation of Bidirectional Neural Bypass System for restoration of hand movement and sensation
University of Glasgow NCT01852279
BCI controlled FES vs. passive therapist controlled FES for improved hand therapy outcomes
18-70 yr Age C4-8 level AIS B, C
Subacute/Chronic Time post-SCI NS
Began 5/2013 Glasgow, UK 20 Subjects
Phase N/A RCT
Parallel Group Double Blind
Manual Muscle Strength ROM
EEG analysis SSEP QIF
Questionnaire
BCI control of FES for Hand Therapy in Spinal Cord Injury
University of California, San Francisco NCT03698149
Brain implantation of cortical electrodes to enable electrocorticography (ECoG) recording of brain activity. Study subjects will undergo training and assessment of their ability to control a wearable hand robotic exoskeleton and/or produce speech
Age>21yrs Limited UE use due to SCI or other neuro disability. Lives close to UCSF
Chronic SCI SCI≥1yr F/U 6yr
Began 8/2018 San Francisco 8 Subjects
Phase 1 Single Group Open Label
Adverse Events associated with ECoG-based interface
Feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control
Shirley Ryan AbilityLab NIH NCT01608438
Comparison of two ways of customizing the body-machine interface over 40 sessions (spread over 8 months). 1) SCI static)—the body-machine interface is static; 2) SCI Machine Learning)—there is a machine learning algorithm that adapts to the movements made by the subject
18-65yr age C3-C6 AIS A, B, C
Time post SCI NS F/U 8m
Began 2/2013 Chicago, IL 46 Subjects
Phase N/A Non-random
Parallel Group Single Blind
Time to task completion (data entry and navigation of virtual or
real obstacle course) Movement Smoothness
UE Strength State-Trait Anxiety Inventory
Subjects drive power wheelchairs, interact with computers through interface that maximizes effectiveness of residual motor function
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
14
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
Vanderbilt University NCT03082898
Indego Exoskeleton walking: three 90minute walking sessions per week for 8 weeks (24 sessions).
Age≥18yr SCI C5 or lower AIS A, B, C, D Non- or Poorly ambulatory FIM gait 1-6
Chronic SCI SCI≥6mos F/U 18wks
Began 11/2016 Tennessee, Florida, Minnesota 24 Subjects
Phase N/A Open Label
Parallel Group AIS A, B AIS C, D
10 Meter Walk Test 6 Minute Walk Test
WISCI-II FIM Gait Score
TUG ISNCSCI
Self-Report Score
Study of exoskeletal walking effects on functional, neurological, and health outcomes
University of Calgary NCT03144830
Indoor, overground walking program using an exoskeleton wearable walking device under the supervision of a physiotherapist. 90 minute sessions, 2-3 times weekly for 8 weeks.
Age≥15yrs C7 and below AIS A, B, C, D Stable spine Adequate ROM
Acute/Subacute SCI SCI<6mos F/U 2 m
Began 6/2016 Calgary, CA 10 Subjects
Phase N/A Single Group Open Label
Cardiorespiratory Status Orthostatic BP & HR Responses
10MWT 6MWT
Perceived Extertion Falls
VAS Pain Scale
Studying safety and feasibility of using an exoskeleton in subjects who are less than 6 months post SCI
James J. Peters VAMC NCT02314221
Use of ReWalk and Ekso Exoskeletons vs. Usual Activity Control Group
18-70yr Age Paraplegia T3 and below (New York) Above T2 (Maryland and New Jersey)
Chronic SCI SCI≥6m F/U 3m
Began 2/2015 New York New Jersey Maryland 64 Subjects
Phase N/A RCT
Crossover Open Label
10 Meter Walk Test 6 Minute Walk Test Timed Up and Go
Advanced Walking Skills Bowel Function
Total Body Fat Mass (DXA)
Study of exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI
Ekso Bionics Burke Med. Res. Inst. NCT02943915
Exoskeleton Gait Training 3X/wk for 12wks vs. standard BWSTT gait training 3X/wk for 12wks or no gait training/usual activity for 12wks to determine effectiveness for improving walking outcomes in participants with chronic incomplete SCI
18-75yr Age C1-T10 AIS C, D Can use Front-Wheeled Walker Amb<0.44m/sec
Chronic SCI Community-dwelling F/U 24 wks
Began 9/2016 Multicenter USA 164 Subjects
Phase N/A RCT
Parallel Group Single Blind
10 Meter Walk 6 Minute Walk
TUG WISCI
ISNCSCI, AIS SCIM III, QoL
Ekso exoskeleton gait training vs. standard gait training vs. no gait training/usual activities for improving walking
Ekso Bionics NCT02566850
Home-setting high dosage use of an Ekso powered exoskeleton device (with a trained spotter at all times)
18-65yr Age Experienced Ekso user requiring≤min assist 60”-76” height
Chronic SCI Community-dwelling F/U 12-36mos
Began 1/2014 Enrolling by invitation Location NS 12 subjects
Phase NA Single Group Open Label
Adverse Events QoL
Bowel & Bladder Function ISNCSCI, Ashworth
SCIM II, Exertion (Borg) Bone Density (DEXA)
Safety and health effects of using the Ekso device (and trained spotter) in a home setting over 12-36 mos
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
15
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
China Medical Univ Hospital NCT03340792
Three 1 hour sessions per week for total of 40 sessions of ambulation training utilizing a ReWalk exoskeleton robot within a 3 month period
20-65yr Age SCI T4 and below
Chronic SCI SCI≥6m F/U 3m
Began 11/2017 China 10 Subjects
Phase N/A Single Group Open Label
Bone Mineral Density by dual X-ray absorptiometry
SF-36 SCI-QOL
Berg Balance Fat Mass/Lean Body Mass
Effects of Ambulation Training Utilizing an Exoskeleton Robot on Subjects With Spinal Cord Injury
Taipei Veterans General Hospital, Taiwan The Industrial Technology Research Institute NCT03548649
At least 20 training sessions (1 hour per session, 2-5 sessions per week) with the FREE Walk exoskeleton robot
18-70yr Age SCI C5-L5 AIS A, B, C, D Can use forearm crutches; cannot walk without assistive device
Chronic SCI SCI≥3m F/U 4-10wks (at the end of 20 sessions)
Began 8/2017 Enrolling by invitation Taiwan 60 Subjects
Phase N/A Single Group Open Label
10MWT TUG
6MWT
Efficacy and safety of a new powered exoskeleton robot for improving walking ability in SCI patients
Montecatone Rehabilitation Institute S.p.A. NCT03443700
EKSO-GT locomotor training plus 8 weeks standard locomotor training vs. 8 weeks of standard locomotor training alone
Age 18-65yr SCI T1-L1 AIS C, D Functional Gait (incl with braces)
Chronic SCI 1yr<SCI<5yrs
Not yet Begun Italy 40 Subjects
Phase N/A Parallel Group Single Blind
10MWT 6MWT
WISCI II Ashworth
LEMS EMG, SSEP, fMRI
RCT on Robotic Exoskeleton in Spinal Cord Injury: Clinical Outcomes and Cortical Plasticity
McGuire Research Institute NCT03410550
Powered exoskeleton (EKSO) 1 hour treatment sessions once or twice a week for 12 weeks
Age 18-70yrs Any SCI Level AIS NS Wt<220lbs
Chronic SCI SCI≥1yr F/U 12wks
Began 7/2018 Richmond, VA 20 Subjects (10 complete SCI, 10 incomplete SCI)
Phase 2 Single Group Open Label
Blood Pressure Walking Time
O2 Uptake Body Composition
6MWT, 10MWT, WISCI II EMG
Studying the effects of exoskeleton walking on cardiovascular, body composition, and walking parameters
University of Texas Houston NCT03057652
algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training using ReWalk, Ekso, and REX systems; randomly assigned order of device use. Up to 15 training sessions per device.
Age≥18yr SCI level NS AIS NS Ashworth <3
Chronic SCI SCI>6m F/U 14-20wks
Began 3/2016 Houston, TX 75 Subjects
Phase N/A RCT
Parallel Group Crossover
Open Label
10 Meter Walk 6 Minute Walk Surface EMG
Oxygen Consumption Gait Kinematics
Bone Mineral Density
Development of an algorithmic-based evaluation and treatment approach for exoskeleton gait training
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. NCT01491789
Single group study of the benefits of the VSail-Access simulator (virtual sailing simulator)
18-55y age SCI >6m SCI C1-S1 AIS A, B, C, D
Chronic SCI>6m F/U 12wks
Began 5/2011 Baltimore, MD 20 Subjects
Phase 1/2 Single Group Open Label
ISNCSCI SCI-QL-23
Functional Reach Grasp/Pinch
Sailing Ability Questionnaire
Studying the benefits of a recreational and therapeutic program for people with SCI using the VSail-Access sailing simulator
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
16
Sponsor/NCT Intervention Inclusion/ Exclusion Criteria
Time Frames Post-SCI
Follow-up
Enrollment Study Phase Study
Design
Outcome Measures Comments
University of Zurich NCT02149186
Interactive Computer-based Therapy System for Legs (iCTuS-L) a virtual reality (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and motor dysfunction
16-80yr age SCI Level NS AIS C, D Has neuropathic pain and/or motor deficits
Acute or Chronic Acute <3m Chronic >1yr F/U 16weeks
Began 10/2009 Zurich, Switzerland 72 Subjects
Phase N/A Single Group Open Label
Questionnaires: Neuropathic Pain, Depression, ADL ,Walking Aids, Personal Assistance, Gait
Transcranial Magnetic Stim
Transcutaneous PN Stim
Interactive Motor Imagery in Virtual Reality
This table is abstracted from the clinical trial registration website www.clinicaltrials.gov using the search term “Spinal Cord Injury” and is updated periodically. The most recent update occurred December 8, 2018 at which time the www.clinicaltrials.gov search found a total of 978 SCI trials. Of these, there were 279 interventional trials that are enrolling or not-yet-enrolling. Review of these 279 studies for those that are targeting improvement in neurological or related functional outcomes yielded the current list. The table includes 85 SCI trials from the search that: 1) are currently actively recruiting or soon-to-be recruiting subjects; 2) are interventional (testing an intervention/treatment) using rehabilitation, neural stimulation and/or assistive technology strategies and 3) targeted improvement in neurological impairment or related activities outcomes. Trials meeting these criteria are included if sufficient information is available on the clinicaltrials.gov webpages to adequately determine basic protocol design, the nature of the intervention, its delivery method, and relevant outcome measures. Interventional clinical trials are routinely registered on www.clinicaltrials.gov based on legal requirements* and because scientific journals may require registration for publication of the trial results. The clinicaltrials.gov website is the largest repository of current and past clinical trials for all diseases and disorders—as of December 8, 2018 the registry contained information on 291,787 trials including research conducted in all 50 states in the USA and 207 countries. Investigators may choose not to register some early phase trials and those testing behavioral interventions, even though they may be important and scientifically rigorous studies.
*U.S. Public Law 110-85 requires the registration and reporting of results of “certain applicable clinical trials,” i.e., controlled interventional clinical trials that are subject to FDA regulation and that involve a Drug or Biologic (other than Phase I investigations), or Device (other than small feasibility studies); http://prsinfo.clinicaltrials.gov/fdaaa.html.
More detailed information on individual trials may be accessed by using the NCT number found in the first column of the table. All trials registered with www.clinicaltrials.gov are assigned a registration number that begins with NCT (e.g. NCT01321333). Entering the NCT number into the search field of www.clinicaltrials.gov or www.google.com will access the webpages describing the trial, the study centers, and contact information in more detail. When an electronic version of the tables is used (e.g. when downloaded as a pdf file from www.scope-sci.org), the webpages describing a specific trial can be directly accessed by using the hyperlink (left Click to follow the link) of the NCT number in the table. Listing of a clinical trial on the clinicaltrials.gov website does not reflect an endorsement SCOPE or by the National Institutes of Health. Information appearing on the clinicaltrials.gov website is provided by study sponsors/investigators and is not verified by SCOPE or clinicaltrials.gov for scientific validity or relevance. Before volunteering to participate in a clinical trial, patients are urged to discuss all options with their healthcare provider and other trusted advisors.
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
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Terms/Abbreviations AIS: the ASIA (American Spinal Injury Association) Impairment Scale is a component of the ISNCSCI that classifies the degree of motor/sensory sparing below the level of injury. The AIS scale ranges from A (most severe, complete injury with no sparing of sensory/motor function in the sacral segments S4-S5 that innervate the anus/rectum) to E (normal). AIS B describes sensory only sparing; AIS C describes sensory and very weak motor sparing; AIS D describes sensory and stronger but not normal motor sparing. Ankle Clonus/foot drop test: a measure of spasticity ARAT: Action Research Arm Test is a clinical measurement of upper limb function Ashworth: an ordinal measurement scale used to rate the severity of spasticity Barthel Index: is an ordinal scale used to measure performance in activities of daily living (ADL). BCI: Brain Computer Interface. Commonly using electroencephalographic (“Brain Wave”) signals to interface with computerized control systems. Berg Balance Scale: A 14-item objective measure designed to assess static balance and fall risk BMCA (Brain Motor Control Assessment): a surface electromyography-based measure of motor output from central nervous system during a variety of reflex and voluntary motor tasks performed under strictly controlled conditions. Borg Perceived Rate of Exertion: a measurement scale of a subject’s perceived effort Box and Blocks Test: a timed functional test to determine gross manual dexterity. BWSTT: Body Weight Supported Treadmill Training COPM (Canadian Occupational Performance Measure): Interview assessment of an individual’s perceived occupational performance in the areas of self-care, productivity, and leisure. CUE: Capabilities of Upper Extremity is a clinical measurement of upper limb function for use in person with tetraplegia (quadriplegia) DASH: Disability of Arm, Shoulder, Hand scale is a measure of the upper limb function
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
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DXA: Dual-energy X-ray absorptiometry is a test which measures bone mineral density EMG: the electromyogram refers to a physiological test of muscle and nerve function. FDA: Food and Drug Administration FES: Functional Electrical Stimulation. Using electrical stimulation of peripheral motor nerves to cause functional contraction of weakened/paralyzed muscles. FMA-UL: Fugl-Meyer Assessment - Upper Limb, an assessment of upper extremity functional capacity Frankel Scale: an older scale for classifying severity of injury that was modified in 1992 to create the AIS. F/U: follow-up GRASSP: Graded Redefined Assessment of Strength, Sensibility, and Prehension is a clinical measurement of upper limb function for use in person with tetraplegia (quadriplegia) H-Reflex: an electrophysiological measure that assesses the monosynaptic reflex; used as a measure of reflex pathway continuity and excitability ICSH: International Classification for Surgery of the Hand in Tetraplegia is a clinical measure of hand function used by surgeons performing reconstructive surgery to improve function in persons with tetraplegia ISNCSCI: International Standards for Neurological Classification of Spinal Cord Injury—sometimes referred to as the ASIA (American Spinal Injury Association) standards. This refers to the accepted international standards for performing motor/sensory physical examination of persons with spinal cord injury and the classification scheme for documenting the neurological level and the severity (completeness) of injury. LE: Lower Extremity MEP: Motor Evoked Potentials, a physiological assessment of motor pathways performed by stimulating the motor cortex of the brain and recording muscle activation responses N/A: not applicable NS: not specified
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
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NRS: Neuromuscular Recovery Scale. Performance assessment of functional motor recovery that includes seated sit up and reverse sit up, sitting ability, trunk extension in sitting, standing ability, walking ability, and sit to stand OOPD: Office of Orphan Product Development Open Label: a trial in which there is no attempt to conceal the identity of the intervention from the subjects; i.e. there is no “blinding” or “masking” of the intervention—the subjects know that they are receiving the “active ingredient” rather than a placebo. Pendulum/Leg Drop Test: a measure of spasticity PGI: Patient Global Impression is a patient reported outcome measurement that rates symptom severity, treatment response, or other specified outcomes on a multipoint scale Phase of Study: Clinical trials usually progress in phases from 1 to 4; Note: trials of rehabilitation and technology interventions are commonly not classified by Phase of Study; i.e. not applicable (N/A) or not specified (N/S)—sometimes documented by investigators as Phase 0
1. Phase 1 trials are usually first-in-human or first-in-disease/condition experiments that are intended to demonstrate feasibility (can it be done), safety (is it reasonably safe), and tolerability (are the side effects tolerable). Phase 1 trials usually do not include a comparison control group and as such, do not provide direct evidence of the interventions efficacy. Phase 1 trials usually enroll a small number of subjects and are commonly done at a single study center but may use a small number of collaborating centers.
2. Phase 2 trials follow successful completion of Phase 1. Phase 2 trials are used to develop information on intervention administration (how to give), dose (how much to give), timing (when and how long to give), effect of the intervention on the body (what does it do, beneficial or harmful). Phase 2 trials commonly utilize multiple study centers, many subjects, and include a randomized control group to provide direct information about efficacy and safety of the intervention. Phase 2 trials enable refinement of how to administer the intervention and how to measure its beneficial effects (what Outcome Measurement to use).
3. Phase 3 trials are conducted using the refined protocols developed from Phase 2 trials. Phase 3 trials are often termed “pivotal” studies because they are sufficiently well-designed and rigorously conducted that their results, if positive, can be used to make the case for regulatory approval (e.g. trials that lead to FDA approval for clinical use). Phase 3 trials almost always enroll large numbers of subjects (in the hundreds or more), use multiple study centers, and randomized control group design (with placebo control and double blinding if feasible). The FDA generally requires two successful confirmatory Phase 3 trials of an intervention for approval.
4. Phase 4 trials are conducted after regulatory (e.g. FDA) approval to gather additional safety and efficacy data. PIADS: the Psychosocial Impact of Assistive Device Scale (PIADS) is a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. RCT: Randomized Controlled Trial—a clinical trial in which subjects are randomly (like flipping a coin) assigned to either receive the active treatment or an alternative (control). Well-designed RCT’s minimize the influence of variables other than the intervention that might have an effect on the desired outcome. For this reason, they provide the best evidence of
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
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efficacy and safety. The most rigorous RCT’s utilize a placebo (inactive) control group and blinding (concealing active vs. control assignment) to minimize bias in the interpretation of study results. SCAR: Spinal Cord Ability Ruler is a test of performance capacity for persons with SCI combining scores of SCIM and the upper limb motor assessments of ISNCSCI SCATSR: Spinal Cord Assessment Tool for Spastic Reflexes, a measure of spasticity SCI-FI: Spinal Cord Injury Functional Index. A measure of physical functioning in persons with SCI SCI-FAP: Spinal Cord Injury Functional Ambulation Profile. Time it takes to do 7 specific walking tasks: 5 meters on carpet, 5 meters on smooth ground while carrying a bag with weights, timed-up-and-go, up and down one step, up and down 4 steps, walking while opening a door, walking over and around obstacles SCI-QOL: Spinal Cord Injury Quality of Life measure SCIM: the Spinal Cord Independence Measure is a measure of a person’s ability to perform certain activities independently; i.e. an outcome measure of a research subject’s independence in the performance of a variety of specific activities. SCI-SET: 7-day recall self-report questionnaire that takes into account both the problematic and useful effects of spasticity on daily life in people with SCI. Sham: is a “faked” clinical trial procedure that omits the elements thought to be therapeutically necessary, analogous to a placebo in a drug trial. Sham procedures are often used in control groups of parallel group trials to enable more accurate assessment of the “active” treatment by enabling blinding of subject and outcome assessor. SSEP: Somatosensory evoked potentials. A physiological assessment of nerve conduction in sensory pathways typically performed by electrically stimulating sensory nerves over the extremities and recording evoked responses with skin electrodes over the sensory cortex of the brain. 6 Minute Walk Test: the distance that can be walked in 6 minutes 2 Minute Walk Test: the distance that can be walked in 2 minutes 10 Meter Walk Test: the time required to walk 10 meters Tardieu Scale: a measure of spasticity utilizing slow vs. fast passive stretch of examined muscle(s) in order to distinguish contracture from spasticity
Spinal Cord Outcomes Partnership Endeavor (SCOPE, www.scope-sci.org) Current SCI Clinical Trials of Rehabilitation and Technological Interventions to Improve Functional Outcomes
Revised December 8, 2018 Listing 85 Trials
21
Transcutaneous Spinal Cord Stimulation (tSCS): stimulation of the spinal cord using electrodes applied to the skin; i.e. stimulation of the spinal cord through the skin TMS, tMS: Transcranial Magnetic Stimulation uses surface (over the scalp) magnetic field stimulation of the motor cortex of the brain to produce motor responses in limb musculature tDCS: Transcranial (through the skull) Direct Current Stimulation uses surface (over the scalp) electrical field stimulation of the motor cortex of the brain to produce motor responses in limb musculature TRI-HFT: Toronto Rehabilitation Institute Hand Function Test, a clinical measure of hand function in which a series of movement and object manipulations are video-taped, timed, and rated for their quality of execution and success. UE: Upper Extremity Wernig Scale: a 6-item (0–5) classification scheme that describes the degree of walking independence with or without ambulatory aids. WISCI: Walking Index for Spinal Cord Injury is an ordinal scale measure for walking capabilities in persons with spinal cord injury WMFT: Wolf Motor Function Test